Pathological and Non-pathological Aging, Physical Activity, Genotype and Cognition

Alzheimer's Disease Clinical Trial

— VIAGECO  

Official title:

Pathological and Non-pathological Aging, Physical Activity, Genotype and Cognition (VIAGECO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02520232
• Other study ID #: CHUBX 2013/22
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: May 11, 2018

Study information

• Verified date: February 2019
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Alzheimer's disease (AD) is an irreversible, progressive brain disease. It is the most common form of dementia and the major cause of functional dependence in the elderly. Since there is currently no cure for Alzheimer's disease, a growing number of scientists pointed out the interest to use non-pharmacological alternative therapeutic approaches in order to slow down the decline of physical and cognitive resources and improve quality of life of patients with Alzheimer's disease. Several narrative and meta-analytical reviews suggest that regular practice of physical activity delays the occurrence of cognitive decline and slows down Alzheimer's disease progress when compared with sedentary people. Despite the growing interest of the scientific community for the positive effects of chronic exercise on mental health and cognitive functions, the clinical reality of this phenomenon remains to be clearly established, more particularly in aged people suffering from neurodegenerative diseases.The first aim of this research project is to test if chronic exercise reduces and even compensates for a cognitive decline in both patients with prodromal Alzheimer's disease (i.e., no dementia) and aging people with no pathology of central nervous system. The second aim of this research project is to examine whether an increasing of cerebral blood flow induced by chronic exercise can explain this positive effect.

Description:

Several epidemiologic studies conducted in North America and in Europe have shown that the regular practice of physical activity, in opposition to a sedentary life, is associated with a reduced risk of developing neurodegenerative diseases such as AD. These results have been strengthened by cross-sectional and interventional studies, which have shown that physical activity slows down the decline of cognitive functions typically observed in normal and pathological aging and retards the onset of dementia. The positive effects of chronic exercise on cerebral and cognitive ageing are now recognised by scientists and clinicians; however, the mechanisms underlying these effects in humans are poorly understood and there is a real need for randomised controlled trial (RCT) on this topic. The objective of this research project is to understand the compensatory mechanisms that may account for the positive effects of regular physical activity on pathological and non-pathological cerebral ageing in human and in particular in people presenting prodromal AD. All participants will be separated into six groups corresponding to the combination of two independent variables: the population type (aged people without any neurological disease vs. prodromal Alzheimer's disease participants) and the type of physical activity program they will follow during six months (aerobic and strength exercise program, stretching and balance program, or maintaining sedentary life style). Cognitive performance, cardiovascular health, brain integrity and cerebral functioning will be assessed at two or three different times: before the onset of the training program (pre-test), at the end of the training period (post-test 1) and six months after the end of the training program (post-test 2).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: May 11, 2018
• Est. primary completion date: February 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• Aged between 60 and 80 years

• Retired

• Complete autonomy on the following four instrumental activities of daily living scales (IADL) : ability to use telephone, mode of transportation, responsibility for own medications and ability to handle finances, level of physical activity practice = 2

• 18.5 = BMI < 40

• MMSE = 25

• For prodromal Alzheimer Disease patients : subjective memory complaints of the participant, objective evidence of impaired encoding in episodic memory (Grober-Buschke free recall score < 17).

Exclusion Criteria:

• Presence of a counter-indication for Magnetic Resonance Imaging , presence of a counter-indication for Positron Emission TomographyScan with [18F]-Flutemetamol, presence of any health problem preventing travel to the imaging service of the University Hospital, being under the legal guardianship of another person or being unable to provide consent to participate

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Behavioral:
• Combination of aerobic and strength exercises
Combination of aerobic and strength exercises
• Stretching and balance exercise program
Stretching and balance exercise program

Locations

Country	Name	City	State
France	University Hospital Bordeaux, France	Bordeaux
France	University Hospital, Poitiers	Poitiers

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Centre National de la Recherche Scientifique, France, Poitiers University Hospital, University of Bordeaux, University of Poitiers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Executive functions (Mean z score)	Mean z score of performances in five tasks involving executive functions (Trail Making Test, Random Number Generation Task, Stroop Color Word Test, Eriksen's Flanker Task, Letter Running Span Task).	0 to 3 months after inclusion visit
Primary	Executive functions (Mean z score)		6 to 9 months after inclusion visit
Primary	Executive functions (Mean z score)		12 to 15 months after inclusion visit
Secondary	Senior Fitness Test score		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Secondary	Body Mass Index		Day 0 (Inclusion visit)
Secondary	Energy expenditure related to physical activity (Actimetry)	Actimetry meseare	3 to 6 months after inclusion visit
Secondary	Heart rate variability at rest		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Secondary	Blood pressure		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Secondary	Depression score		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Secondary	Self-efficacy score		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Secondary	Quality of life score		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Secondary	Stage of change score related to physical activity		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Secondary	Score at Verbal working-memory span		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Secondary	Reaction time in a two-choice reaction time task		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Secondary	Error rate in a two-choice reaction time task		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Secondary	Logic memory score		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Secondary	Grey and white matter volumes in regions of interest		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit
Secondary	Cerebral perfusion in the same regions of interest	Brain Imaging	0 to 3 months after inclusion visit ; 0 to 15 days after inclusion visit ; 6 to 9 months after inclusion visit
Secondary	Resting State Networks Activity	Brain Imaging	0 to 3 months after inclusion visit ; 0 to 15 days after inclusion visit ; 6 to 9 months after inclusion visit
Secondary	Brain glucose metabolism	Brain Imaging	0 to 3 months after inclusion visit ; 0 to 15 days after inclusion visit ; 6 to 9 months after inclusion visit